CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
---|---|---|---|---|---|---|---|
CE Marking: Yes | Manufacturer: Metas Biomedical Inc. | Commercial: ImmTek COVID-19 Antigen Rapid Test | Device ID: 1928 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Hangzhou Immuno Biotech Co. Ltd. | Commercial: Immunobio SARS-CoV-2 Antigen ANTERIOR NASAL Rapid Test Kit (minimal invasive) | Device ID: 1844 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: PHASE Scientific International Limited | Commercial: INDICAID COVID-19 Rapid Antigen Test Kit | Device ID: 3014 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Affimedix Inc. | Commercial: InfectCheck® - COVID-19 IgG/IgM Test | Device ID: 2136 | Method: Immunochromatography | Target: IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Affimedix Inc. | Commercial: InfectCheck® COVID-19 NAb Test | Device ID: 2137 | Method: Immunochromatography | Target: IgG | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Zhejiang Orient Gene Biotech Co. Ltd. | Commercial: Influenza & COVID-19 Ag Combo Rapid Test | Device ID: 3095 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Hoyotek Biomedical Co. Ltd. | Commercial: Influenza A/B/Corona Virus (COVID-19) Antigen Rapid Test (Colloidal Gold) | Device ID: 1931 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Türklab Tibbi Mal. San. ve Tic. A.S. | Commercial: INFO Covid-19 Ag Test | Device ID: 2584 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Türklab Tibbi Mal. San. ve Tic. A.S. | Commercial: INFO SARS-CoV-2 IgM/IgG Ab Test | Device ID: 1753 | Method: Immunochromatography | Target: IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: EUROFINS INGENASA | Commercial: INGEZIM COVID 19 SPIKE CROM | Device ID: 2458 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
CE Marking: No | Manufacturer: Innovation Scientific Pty Ltd. | Commercial: InnoScreenTM COVID-19 IgG/IgM Rapid Test Device | Device ID: 2565 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: SG Medical Inc. | Commercial: InstaView COVID-19 Antigen | Device ID: 2935 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: DIESSE Diagnostica Senese SPA | Commercial: iRAPID SARS-CoV-2 QUANT “NEUTRALIZING” Ab | Device ID: 2732 | Method: Immunochromatography | Target: IgG | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Hangzhou GENESIS Biodetection and Biocontrol Co. Ltd. | Commercial: KaiBiLi COVID-19 Antigen | Device ID: 2085 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Hangzhou GENESIS Biodetection and Biocontrol Co. Ltd. | Commercial: KaiBiLi COVID-19 Antigen Pro | Device ID: 2885 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Hangzhou GENESIS Biodetection and Biocontrol Co. Ltd. | Commercial: KaiBiLi Flu & COVID-19 Antigen Duo | Device ID: 2890 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: NATRIX S.R.L. | Commercial: KIT REVOLUTION COVID-19 ANTIGENIC TEST FOR SARS-COV-2 | Device ID: 2348 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: NATRIX S.R.L. | Commercial: KIT REVOLUTION COVID-19 RAPID SALIVARY TEST FOR SARS-COV-2 | Device ID: 2349 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Asan Pharmaceutical Co. Ltd. | Commercial: KNAX-SMART SARS-CoV-2 Ag | Device ID: 2535 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Asan Pharmaceutical Co. Ltd. | Commercial: KNAX-SMART SARS-CoV-2 IgM/IgG (N) | Device ID: 2571 | Method: Immunochromatography | Target: IgG, IgM | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Asan Pharmaceutical Co. Ltd. | Commercial: KNAX-SMART SARS-CoV2 Influenza A&B Ag combo | Device ID: 2536 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Vatic Health Ltd. | Commercial: KnowNow SARS-CoV-2 Rapid Antigen Test | Device ID: 2508 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: BIOSYNEX S.A. | Commercial: KSMART COVITOP | Device ID: 3113 | Method: Immunochromatography | Target: Antigen | Format: | Go to details |
CE Marking: Yes | Manufacturer: AVALUN SAS | Commercial: Ksmart® SARS-COV2 Antigen Rapid Test | Device ID: 1800 | Method: Immunochromatography | Target: Antigen | Format: Semi-automated | Go to details |
CE Marking: Yes | Manufacturer: Koroglu Medikal Tibbi Malzemeleri Kozmetik Ithalat Ihracat San. Ve Tic Ltd. Sti. | Commercial: Laboquick COVID 19 Ag Rapid Test Kit | Device ID: 2786 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Lifeassay Diagnostics Pty Ltd. | Commercial: LEPZI Qualitative COVID-19 Test | Device ID: 3151 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Spartacus-Biomed | Commercial: LFA COVID-19 IgG & IgM Rapid Test Device | Device ID: 2186 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Shanghai Liangrun Biomedicine Technology Co. Ltd. | Commercial: LionRunTM SARS-CoV-2 Antigen Rapid Test (Lateral Flow Immunoassay) | Device ID: 2155 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Zhuhai Livzon Diagnostics Inc. | Commercial: Livzon Rapid Test for SARS-CoV-2 Antigen (Lateral Flow) | Device ID: 1441 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Hunan Zonka Biotech Co. Ltd. | Commercial: LollyTest 2019-CoV Ag Saliva Rapid Test Card | Device ID: 2470 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Hunan Zonka Biotech Co. Ltd. | Commercial: LollyTest 2019-nCoV Ag Rapid Test Kit | Device ID: 2473 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Hunan Zonka Biotech Co. Ltd. | Commercial: LollyTest 2019-nCoV IgG&IgM Antibody Rapid Test Kit | Device ID: 2474 | Method: Immunochromatography | Target: IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Lomina Sperbio a.s. | Commercial: Lomina SARS-CoV-2 Antigen LTX Selftest | Device ID: 3678 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Lomina Superbio a.s. | Commercial: Lomina SARS-CoV-2 Antigen LTX Selftest | Device ID: 4070 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Lomina Superbio a.s. | Commercial: Lomina SARS-CoV-2 Antigen LTX test | Device ID: 2560 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Lomina Superbio a.s. | Commercial: Lomina SARS-CoV-2 Antigen LTX test (saliva) | Device ID: 2765 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Lomina Superbio a.s. | Commercial: LOMINA SARS-CoV-2 N-Protein Antigen Rapid Test | Device ID: 2158 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC, Semi-automated | Go to details |
CE Marking: Yes | Manufacturer: Lomina Superbio a.s. | Commercial: Lomina SARS-CoV-2+ Influenza A/B Antigen LTX Test | Device ID: 4147 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: LUCA AICELL Inc. | Commercial: LUCA NK COVID-19 Ag LLB | Device ID: 2654 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: LUCA AICELL Inc. | Commercial: LUCA NK COVID-19 Ag Nasal LLB | Device ID: 2668 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: LUCA AICELL Inc. | Commercial: LUCA NK COVID-19 Ag NP LLB | Device ID: 2670 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: LUCA AICELL Inc. | Commercial: LUCA NK COVID-19 Ag Saliva LLB | Device ID: 2669 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: ZEKMED Ltd. | Commercial: LUNA AG - Hybrid Antigen Test Kit | Device ID: 2837 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: MEDICE Arzneimittel Pütter GmbH & Co. KG | Commercial: Medicovid-AG SARS-CoV-2 Antigen Schnelltest-Nase | Device ID: 2526 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Medifood Hungary Innovation Kft. | Commercial: MediDia COVID-19 Ag | Device ID: 2973 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: MEDsan® GmbH | Commercial: MEDsan® SARS-CoV-2 Ag Duo | Device ID: 3954 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Jiangxi Province JinHuan Medical Instrument Co. Ltd. | Commercial: MEDSYS Novel Coronavirus (SARS-CoV-2) Antigen Rapid Detection Kit | Device ID: 3004 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Meril Diagnostics Pvt Ltd. | Commercial: MERISCREEN COVID-19 Antigen Detection Test | Device ID: 2582 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: MiCo Biomed Co. Ltd. | Commercial: MiCo BioMed Co., Ltd. | Device ID: 2827 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: möLab | Commercial: mö-screen Corona Antigen Test | Device ID: 1190 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements